The Effects of Cannabidiol and ∆-9-THC in Humans

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Yale University
Sponsor:
Information provided by (Responsible Party):
Mohini Ranganathan, Yale University
ClinicalTrials.gov Identifier:
NCT01180374
First received: August 10, 2010
Last updated: June 13, 2014
Last verified: June 2014
  Purpose

Cannabis is the most commonly used illicit substance in the US and herbal cannabis consists of a number of cannabinoids including Δ-9 THC and CBD. This study will characterize the interactive effects of the two major components of cannabis i.e. Δ-9-THC and CBD.


Condition Intervention Phase
Healthy
Drug: Cannabidiol
Drug: Delta-9-THC
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Cannabidiol Modulation of ∆-9-THC's Psychotomimetic Effects in Healthy Humans

Resource links provided by NLM:


Further study details as provided by Yale University:

Primary Outcome Measures:
  • Behavioral Measures [ Time Frame: Baseline, +15, +80, +240 ] [ Designated as safety issue: No ]
    Subjective effects, perceptual alterations, and cognitive effects will be assessed using visual analog scales, Positive and Negative Symptom Subscale (PANSS), Clinician Administered Dissociative States Scale (CADSS), Psychotomimetic States Inventory (PSI) and a neuro cognitive battery.


Estimated Enrollment: 75
Study Start Date: June 2010
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Active Canabidiol and Active Delta-9-THC Drug: Cannabidiol
Active Cannabidiol 5mg.
Drug: Delta-9-THC
Active Delta-9-THC (0.035mg/Kg) given intravenously over 20 minutes. The dose of THC that you may receive is a small dose and is roughly equivalent to smoking approximately one half to one whole marijuana cigarette, or "joint".
Placebo Comparator: Placebo and Active Delta-9-THC Drug: Delta-9-THC
Active Delta-9-THC (0.035mg/Kg) given intravenously over 20 minutes. The dose of THC that you may receive is a small dose and is roughly equivalent to smoking approximately one half to one whole marijuana cigarette, or "joint".
Drug: Placebo
Placebo (about a quarter spoon of alcohol with no CBD).
Experimental: Active Cannabidiol and Placebo Drug: Cannabidiol
Active Cannabidiol 5mg.
Drug: Placebo
Placebo (about a quarter spoon of alcohol with no THC) given intravenously over 20 minutes.
Placebo Comparator: Placebo and Placebo Drug: Placebo
Placebo (about a quarter spoon of alcohol with no CBD).
Drug: Placebo
Placebo (about a quarter spoon of alcohol with no THC) given intravenously over 20 minutes.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Exposed to Cannabis at least once in lifetime

Exclusion Criteria:

  • Cannabis Naive
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01180374

Contacts
Contact: Prerana Purohit, B.A. 203-932-5711 ext 4495 prerana.purohit@yale.edu

Locations
United States, Connecticut
VA Connecticut Healthcare System Recruiting
West Haven, Connecticut, United States, 06516
Contact: Prerana Purohit, B.A.    203-932-5711 ext 4495    prerana.purohit@yale.edu   
Principal Investigator: Mohini Ranganathan, M.D.         
Sponsors and Collaborators
Yale University
Investigators
Principal Investigator: Mohini Ranganathan, M.D Yale University Medical School
  More Information

No publications provided

Responsible Party: Mohini Ranganathan, Principal Investigator, Yale University
ClinicalTrials.gov Identifier: NCT01180374     History of Changes
Other Study ID Numbers: 1001006240
Study First Received: August 10, 2010
Last Updated: June 13, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Yale University:
Cannabis
Marijuana
Cannabidiol
CBD
THC
Psychotic Disorders

Additional relevant MeSH terms:
Dronabinol
Hallucinogens
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Cannabinoid Receptor Agonists
Cannabinoid Receptor Modulators
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on August 28, 2014